A new public dashboard has been launched by the Food and Drug Administration (FDA) for public access to data for drugs with approved Risk Evaluation and Mitigation Strategy (REMS.) According to FDA, This new dashboard includes visualizations and charts for total and active REMS programs, elements to assure safe use, REMS modifications, revisions, and released REMS programs that are no longer in effect. This new dashboard does not intend to replace the current FDA REMS database but rather to add additional opportunity for analysis and insight.

What is REMS?

REMS is an abbreviation for Risk Evaluation and Mitigation Strategy. This strategy was implemented by FDA as a drug safety program that is implemented for drugs that raise serious safety concerns. The goal is to ensure that the drug provides a greater benefit than the risk to consumers. According to the FDA, some examples of the types of risk that REMS intends to mitigate include serious infection, severe infection, liver damage, and severe birth defects. Drugs in scope include Rx drugs (New Drug Applications, Abbreviated New Drug Applications) and Biologics (certain Biologic License Applications,) but not over-the-counter (OTC) drugs. REMS can be required prior to FDA approval or post-approval if FDA becomes aware of new safety information.

REMS come in two forms: basic and REMS with ETASU (elements to assure safe use.) According to FDA, ETASU is required medical interventions or other actions by healthcare professionals prior to prescribing or dispensing the drug. Some actions may also be required in order for the patient to continue on treatment. A REMS can require any of the following based on risk:

• Certification or specialized training of HCPs who prescribe the drug
• Certification of pharmacies or other dispensers of the drug
• Dispensing/administration of the drug in limited settings, e.g., hospitals
• Dispensing/administration of drug only with evidence of safe-use conditions
• Each patient using the drug is subject to certain monitoring
• Enrollment of treated patients in registries

As of 2022, 90% of current REMS include ETASU.

Types of submissions include standard (one sponsor with one-to-many products) and Single Shared System (SSS) REMS (multiple sponsors with multiple products.) As of 2021, 92% of REMS were standard and only 8% were SSS REMS. As the same check point, 41% of sponsors submitted only standard REMS, 50% submitted SSS REMS and 9% submitted both.

Still a little unclear? Check out our REMS Glossary!

What’s next for REMS?

In accordance with the final guidance issued in 2020, FDA will be requiring REMS to be submitted in Structured Product Labeling (SPL) format beginning December 28, 2022. To learn more, register for the upcoming Reed Tech webinar, REMS in SPL How to comply with the FDA submission requirement, Wednesday, April 20th at 2 PM ET.

For help with your submissions or more information, contact Reed Tech at [email protected] or +1 (215) 557-3010.